Regulatory issues

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inspection , College of American Pathologists (CAP) checklists , Joint Commission , American Association of Blood Banks (AABB) accreditation , Food and Drug Administration (FDA) regulations , Centers for Medicare & Medicaid Services (CMS), Clinical Laboratory Improvement Act (CLIA), current CLIA regulations , non-profit hospital , public hospitals , for-profit hospital

Read about

CLIA 1988

Pathology services have to reconcile the demands of providing high-quality and accurate laboratory testing for hundreds if not thousands of patients each year. In 1988, following public furor over the deaths of women that were attributed to false-negative readings of Pap smears, Congress passed CLIA , or the Clinical Laboratory Improvement Act , to regulate every test performed in every laboratory in the United States. Laboratory tests, as defined in CLIA, are subdivided into three categories by complexity and impact:
  • “waived” tests are simple tests with little negative outcome even if performed incorrectly
  • “moderately complex” tests are those that are more complex than waved tests but usually automated, and so have little chance of error (e.g. blood counts, routine chemistries)
  • “highly complex” tests are usually not automated and require considerable judgment (e.g. microbiology, cross-matching of blood)

CLIA requires an inspection of laboratories every two years by an approved agency. For laboratory tests of moderate or high complexity, there must also be an on-site survey/inspection. Inspection of clinical laboratories for both quality and safety has been performed since the early 1990s by various accreditation agencies, including College of American Pathologists (CAP), the Joint Commission (JCAHO), Centers for Medicaid and Medicare Services (CMS), and American Association of Blood Banks (AABB).


Within the FDA, the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) regulates in-home and laboratory diagnostic tests, also called in vitro diagnostic devices (IVDs). The functions of the OIVD (from their website) are the following:
  • Helps good new IVDs reach the medical market
  • Prevents the sale of unsafe or ineffective IVDs
  • Categorizes the complexity of IVDs according to the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88), thereby defining the type of regulatory oversight applied to the product


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This page was last modified by - JYKim_Path JYKim_Path on Nov 30, 2009 9:24 am.